NobelProcera Esthetic Zirconia Implant Bridge 8unit B1
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- NobelProcera® Esthetic Zirconia Implant Bridge 8unit B1 EUDAMEDNobelProcera® FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Prostheses Zr - Multi-unit EUDAMEDNobelProcera® Esthetic Zirconia Implant Bridge 8unit B1 FDA UDI
- Model / Reference
- 88679 EUDAMEDFDA UDI
- Description
- NobelProcera® Esthetic Zirconia Implant Bridge 8unit B1 FDA UDI
Identifiers
- Catalog Number
- 88679 FDA UDI
- Primary DI / UDI-DI
- 07332747203578 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000002136V EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The NobelProcera Esthetic Zirconia Implant Bridge 8unit B1 is a dental prosthesis designed for multi-unit zirconia-based implant-supported restorations, classified under nomenclature code P01020101. This fixed dental prosthesis is intended for use in replacing multiple adjacent teeth by connecting to dental implants, providing a durable and esthetic solution for patients requiring full-arch or partial restoration.
This single-use, non-reusable, implantable device is supplied as a zirconia-based bridge requiring surgical placement by a dental professional. It is not sterile at time of supply and must be handled in a controlled clinical environment prior to use. The device carries FDA 510K and MDR authorisations, adhering to Class IIb risk classification standards. Storage and handling must comply with manufacturer guidelines to ensure integrity before surgical application.
Frequently asked questions
What is the NobelProcera Esthetic Zirconia Implant Bridge 8unit B1 used for in clinical practice?
This device is designed as a fixed dental prosthesis for multi-unit zirconia-based implant-supported restorations. It replaces multiple adjacent missing teeth by connecting to dental implants, offering a durable and aesthetically pleasing solution for patients needing full-arch or partial restorations. It is specifically categorized under nomenclature code P01020101 for dental prostheses.
Is the NobelProcera Esthetic Zirconia Implant Bridge 8unit B1 intended for single-use or repeated use?
The device is explicitly marked as non-reusable (REUSABLE: 0) and must be treated as a single-use implantable prosthesis. It is not designed for reprocessing or reuse, requiring surgical placement by a dental professional during a single procedure.
How should the NobelProcera Esthetic Zirconia Implant Bridge 8unit B1 be handled before use?
The device is not sterile at time of supply (STERILE: 0) and must be handled in a controlled clinical environment prior to use. Proper sterilization procedures must be followed as per the manufacturer’s guidelines before surgical placement, ensuring compliance with clinical protocols for implantable devices.
What regulatory pathways does the NobelProcera Esthetic Zirconia Implant Bridge 8unit B1 follow?
The device holds FDA 510K clearance and MDR authorization, adhering to Class IIb risk classification standards. These regulatory pathways confirm its compliance with safety and performance requirements for dental implant prostheses in the respective markets.
How is the device identified for ordering or inventory purposes?
The device carries a Basic UDI (Unique Device Identifier) of 73327470000002136V and a UDI-DI (Device Identifier) of 07332747203578 for traceability. This UDI system ensures accurate identification for regulatory, inventory, and clinical tracking purposes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202452 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K240346 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K091907 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 73327470000002136V | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (3)
- EUDAMED f28a1b5c-6bd2-4e4b-a502-496ed8982b06 61 fields · synced Oct 6, 2026
- FDA UDI a47c2dd0-85a6-44c3-9a8c-c62abde9e4b8 36 fields · synced May 29, 2026
- FDA 510(k) K202452 1 fields · synced May 18, 2026